TINA-QUANT ALBUMIN GEN.2

Additional Manufacturer Narrative

THE FIELD SERVICE ENGINEER FOUND THERE WAS AN ISSUE WITH THE REAGENT PACK. HE CLEANED AND ADJUSTED THE REAGENT PROBE, AS A WHITE CRUST WAS PRESENT. THE CUSTOMER LOADED A NEW REAGENT PACK AND PERFORMED CALIBRATION, QC, AND PRECISION TESTING. BASED ON THE INFORMATION PROVIDED, THE INVESTIGATION WAS UNABLE TO DETERMINE A SPECIFIC ROOT CAUSE. THE INVESTIGATION DETERMINED THE ISSUE WAS RESOLVED BY THE SERVICE AND CUSTOMER ACTIONS.

Additional Manufacturer Narrative

THE COBAS C 503 ANALYTICAL UNIT SERIAL NUMBER WAS (B)(6). THE INVESTIGATION IS ONGOING.

Description of Event or Problem

THERE WAS AN ALLEGATION OF QUESTIONABLE TINA-QUANT ALBUMIN GEN.2 (MIROALBUMIN) RESULTS FOR URINE SAMPLES FROM THE COBAS C 503 ANALYTICAL UNIT. THE SAMPLES WERE REPEATED ON THE SAME ANALYZER AND THEN ANOTHER COBAS C 503 ANALYTICAL UNIT. SAMPLE (B)(6) INITIAL RESULT WAS 98.6 MG/L, AND THE REPEAT RESULTS WERE 20.8 MG/L AND 3.3 MG/DL WITH A DATA FLAG (REPORTED AS <12.0 MG/L). SAMPLE (B)(6) INITIAL RESULT WAS 32.4 MG/L, AND THE REPEAT RESULTS WERE 5.28 MG/L WITH A DATA FLAG (REPORTED AS <12.0 MG/L) AND 4.12 MG/L WITH A DATA FLAG (REPORTED AS <12.0 MG/L). THE REPEAT RESULTS FROM THE OTHER ANALYZER WERE BELIEVED TO BE CORRECT.